Ohio Firm Recalls Mis-Formulated Ice Cream Bars with Allergen Concern

Jeni’s Splendid Ice Creams, Columbus, Ohio, is voluntarily recalling one batch of Passion Fruit Dreamsicle Ice Cream Bars because they may contain undeclared wheat and soy.  The recall was initiated after a crunch topping from a separate product was inadvertently introduced to this particular batch of Passion Fruit Dreamsicle Ice Cream Bars during manufacturing. The crunch topping contains wheat and soy, which is not declared on the packaging.

This is a case of mis-formulation with a post-process addition of the crunch topping containing the allergens. (The added allergens are bad enough, but nobody wants a crunch topping on their smooth-tasting passion fruit dreamsicle.  Just wrong.)

This product was distributed in grocery stores nationwide.  No illnesses or injuries have been reported to date.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/jenis-splendid-ice-cream-voluntarily-recalls-passion-fruit-dreamsicle-ice-cream-bars-due-undeclared
“Jeni’s Splendid Ice Cream Voluntarily Recalls Passion Fruit Dreamsicle Ice Cream Bars Due to Undeclared Wheat and Soy.”
Summary
Company Announcement Date:  November 17, 2025
FDA Publish Date:  November 18, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared allergen - soy, wheat.
Company Name:  Jeni’s Splendid Ice Cream
Brand Name:  Jeni’s
Product Description:  Passion Fruit Dreamsicle Ice Cream Bars

Congress Restricts Use of THC in Food

Over the past few years, we have seen a number of food products containing THC, especially beverages and gummies.  These products came about from a loophole in the 2018 Farm Bill that "that allowed hemp-derived products containing tetrahydrocannabinol, or THC to be sold."

Congress decided to close this loophole and enacts stricter rules for hemp specifically a much lower limit for THC, the chemical that gives marijuana its psychological effects.  The bill will ban any products with more than 0.4 milligrams of THC.

USA TODAY
https://www.usatoday.com/story/news/nation/2025/11/15/hemp-loophole-familiar-products-could-be-banned/87249690007/
New law puts familiar drinks, creams and gummies in legal limbo
The provision closes a loophole that allowed hemp-derived products containing THC to be sold. Even products not marketed for their THC content may face legal problems.
Phaedra Trethan and Jeanine Santucci
November 15

The legislation to reopen the government also included strict new rules for hemp products that critics say threaten to outlaw mainstream drinks, creams, gummies, oils and vapes.

Oregon Creamery Recalls Cheese After FDA Testing Finds Listeria in Environment

Face Rock Creamery LLC of Bandon, OR is voluntarily recalling 16/6oz. units of Vampire Slayer Garlic Cheddar with a use-by date of 11/04/26 because it has the potential to be contaminated with Listeria monocytogenes.  This recall is the result of an FDA environmental sample that identified the presence of Listeria monocytogenes in the processing area where this cheese was packaged. Finished product has not been tested positive for any contaminants.

The product was sold exclusively at Face Rock Flagship store in Bandon, Oregon.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/face-rock-creamery-llc-recalls-6oz-vampire-slayer-garlic-cheddar-because-possible-health-risk
Face Rock Creamery LLC Recalls 6oz. Vampire Slayer Garlic Cheddar Because of Possible Health Risk
Summary
Company Announcement Date:  November 14, 2025
FDA Publish Date:  November 15, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Potential to be contaminated with Listeria monocytogenes
Company Name:  Face Rock Creamery LLC
Brand Name:  Face Rock Creamery
Product Description:  Vampire Slayer Garlic Cheddar cheese

A Case of Toxic Squash Syndrome From Excessive Consumption of Gourd Juice

A Canadian woman became extremely ill suffering from toxic squash syndrome, or bitter bottle gourd poisoning" after consuming homemade juice from the calabash or bottle gourd.

After daily consumption of the juice, she was experiencing sudden weakness, nausea, vomiting, diarrhea and lower abdominal pain.  Medical tests "revealed that the woman's heart rate and breathing rate were high, and her blood pressure was initially high and then fell concerningly low. Her extremities were also unusually cool to the touch, indicating she had poor circulation. Meanwhile, one of the chambers of her heart was pumping very forcefully, and an echocardiogram suggested she was having other heart issues."  Internal investigation found her "stomach lining was inflamed and bleeding as a result of tissue damage, which was likely caused by poor oxygen delivery to the tissue."

The issue was the level of cucurbitacins.  An AI entry provides that these are "bitter-tasting chemical compounds found in plants of the Cucurbitaceae family (like cucumbers, melons, and squash), which protect wild plants from predators. While they can be toxic in high concentrations, especially in wild or improperly cultivated varieties, domesticated plants are bred to have low levels. Research indicates that cucurbitacins have potential medicinal uses, such as anti-inflammatory, antioxidant, and anticancer properties, but further research is needed to evaluate safety and efficacy. "

Why would she consume this?  Evidently, cucurbitacins have potential health benefits including ani-cancer, anti-inflammatory, liver health, hair growth, and anti-diabetic.  But this is 'potential' in that they are not fully understood, especially regarding dosage.  And controlled dosage can be difficult to manage when someone is just pureeing these at home in their food processor and consuming every day.  A good message to remember here is, "to live by the gourd, is to die by the gourd".


Live Science
https://www.livescience.com/health/food-diet/diagnostic-dilemma-a-womans-homemade-juice-led-to-life-threatening-toxic-squash-syndrome
Diagnostic dilemma: A woman's homemade juice led to life-threatening 'toxic squash syndrome'

Features

By Nicoletta Lanese published November 12, 2025

FDA Warning Letter to RTE Facility Highlights Inadequate Environmental Control That Resulted in Listeria Outbreak

The Warning Letter discussed here is a good example of not properly identifying and implementing a Sanitation Preventive Control in a RTE facility.  This facility had an ongoing Listeria contamination issue that had was not rooted out and eliminated.

FDA issued a Warning Letter to Fresh & Ready Foods LLC, San Fernando, CA, a division of Compass Foods, a manufacturer of ready-to-eat (RTE) sandwiches, salads, wraps, snack items, and entrees. The inspection was initiated as part of a multistate foodborne outbreak investigation of Listeria monocytogenes (L. monocytogenes) in which ten (10) people from two (2) states (California and Nevada) have been infected with the outbreak strain of L. monocytogenes.  

FDA environmental testing revealed that the clinical isolates match two (2) environmental swabs taken from production area during the FDA inspection of the facility (March 31 to April 15, 2025).

Did not consider environmental pathogens as a significant hazard warranting a preventive control, because of using prerequisite programs (SSOPs)  - "While the facility’s written hazard analysis considered biological pathogens such as L. monocytogenes at the RTE product preparation, assembly, and (b)(4) steps, they determined this hazard was not reasonably likely to occur and did not require a preventive control due to your Sanitation Standard Operational Procedures (SSOPs) and Good Manufacturing Procedures (GMPs). However, your RTE products are exposed to the environment prior to packaging and do not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen."

Their approach was shown to be inadequate "as evidenced by the following analytical results, the SSOPs and GMPs are not adequate to ensure that [the] facility is maintained in a sanitary condition to significantly minimize or prevent the hazard of environmental pathogens such as L. monocytogenes

The positive findings included the food-contact surfaces of a:

- Conveyor belt and roller where in-process RTE sandwiches were placed.

- Slicer 3-gauge plate/knife cover which is used to slice component ingredients for RTE sandwich and wrap products.

Interesting was that this was not the first time L. monocytogenes was found in the facility by FDA. "In 2017, FDA detected L. monocytogenes in (b)(4) environmental swabs, which included a swab collected from a direct food-contact surface taken from a mixing bowl.  The company indicated they would implement corrective actions at that time.  However, the "reoccurring presence of L. monocytogenes in [the] facility is significant in that it demonstrates [the] sanitation efforts have been inadequate to effectively control or prevent L. monocytogenes in your facility so as to prevent contamination of food."

The company indicated they took corrective action after the FDA inspection, however, they did not provided sufficient verification to FDA that the measures taken were adequate.  The report states that the company has "not provided any additional information regarding your investigation on identifying the sources of L. monocytogenes to show that you have located and eradicated the harborage site(s), your updated food safety plan, your revised sanitation preventive control program, details regarding your revised environmental monitoring program to identify the target test microorganism, and the analytical methods you will be using. You also did not provide any of your associated cleaning and sanitation records to reflect your corrective actions, and you did not provide any training records that demonstrate your employees have been trained in proper sanitation."

Other issues

• Metal control - did not appropriately evaluate physical hazards such as metal, to determine whether it is a hazard requiring a preventive control in your RTE products.id not have adequate controls in place, as evidenced by missing metal lacing segments observed on Lines (b)(4) conveyor belts on March 31, 2025. Further, product manufactured on Line (b)(4) did not pass through a metal detector. Missing metal lacing segments is a repeat observation from our previous inspection of your facility.
• Supply chain program for RTE Ingredients - 'did not appropriately evaluate the hazard of biological pathogens associated with the ingredients as a known or reasonably foreseeable hazard requiring a preventive control, although there is a vendor approval program for ingredients. The facility produces ready-to-eat products containing ingredients with reasonably foreseeable biological hazards (specifically, chilled RTE produce) that do not undergo a validated (b)(4) step or other adequate lethality treatment within your facility to eliminate these identified hazards. Therefore, for those ingredients, one is required to establish and implement a supply chain program'

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/compass-group-usa-709592-09052025
WARNING LETTER
Compass Group USA
MARCS-CMS 709592 — September 05, 2025

First Reported Case of a Fatality Due to "Meat Allergy" Associated with Tick Bite

UVA Medical researchers are reporting the first death associated with someone have the 'meat allergy' acquired from getting bit by a Lone Star tick.

"A healthy 47-year-old man from New Jersey died abruptly four hours after consuming beef. The cause of his death had been a mystery until UVA Health’s Thomas Platts-Mills, MD, PhD, investigated. A world-renowned allergist, Platts-Mills discovered the allergy and remains the foremost expert on it."

"The allergy is caused by the bite of the Lone Star tick. Bites can sensitize people to alpha-gal, a sugar found in mammalian meat. People who become sensitized to the sugar can have allergic symptoms such as rash, nausea and vomiting after eating beef, pork or lamb. Researchers have feared that deadly anaphylaxis was possible in severe cases but had not confirmed a fatality from the allergy until now."

I thought this was very interesting.

"When asked about his history of tick bites, the man’s wife said he had none this past year but had 12 or 13 chigger bites around his ankles this summer. Platts-Mills realized that many “chigger bites” in the Eastern United States are actually bites from Lone Star tick larvae."

Eureka Alert
https://www.eurekalert.org/news-releases/1105793
1st death linked to ‘meat allergy’ spread by ticks
Peer-Reviewed Publication
University of Virginia Health System

University of Virginia School of Medicine researchers have identified the first death caused by what is commonly called the “meat allergy” being spread by ticks.

Australia - Improper Design of Labels on Bottles of Plant Milk Led to Botulism Case

In Australia, a food company was fined when product was labeled with a improperly designed label that led to a case of botulism.  Bottles of almond and oat milk had labels that read '“once opened, keep refrigerated and consume within 5 days” and should have stated, "Keep Refrigerated".  A customer bought the plant-based milk and then stored it on the shelf in kitchen rather than the refrigerator, and after a person drank the improperly stored milk-type product, they became ill with botulism poisoning.  That person spent 147 days in the ICU as their bodies overcame the effects of the neurotoxin. 

“The incorrect content of the label was originally prepared for use on another, shelf-stable Ultra High Temperature (UHT) product offering, and was then inadvertently copied across to the new product packaging,” Judge Payne said.

The fine was $200,000..which seems pretty light for a botulism case by US standards.

This is a good reminder how important label design and approval is for the safety of the product.  Allergens are often the issue with label design, but in this case, safe handling instructions.

https://www.news.com.au/lifestyle/health/health-problems/honest-oversight-almond-milk-label-error-lands-man-in-icu-for-147-days/news-story/e5316c0db9882d26f1b0a94932bc6adb
‘Honest oversight’: Almond milk label error lands man in ICU for 147 days
A man's 188-day hospital nightmare has led to heavy penalties for a milk company whose labelling error caused one of Australia's rarest poisoning cases.
Sarah Keoghan
November 6, 2025 - 2:16PM

Recall Notice of Prosecco Bottles Due to Potential for Exploding

On November 6, 2025, the U.S. Consumer Product Safety Commission announced a recall of  Kirkland Signature Valdobbiadene Prosecco DOCG due to exploding.   However the recall for the same product, including the same lot code dates, was posted in September. (https://pennstatefoodsafety.blogspot.com/2025/09/costco-issues-recall-for-prosecco-due.html).

So probably just a delay for the USCPSC getting this posted.

United States Consumer Product Safety Commission

https://www.cpsc.gov/Recalls/2026/F-F-Fine-Wines-Recalls-Kirkland-Signature-Valdobbiadene-Prosecco-DOCG-Bottles-sold-by-Costco-Due-to-Laceration-Hazard

F&F Fine Wines Recalls Kirkland Signature Valdobbiadene Prosecco DOCG Bottles sold by Costco Due to Laceration Hazard
Name of Product: Kirkland Signature Valdobbiadene Prosecco DOCG bottles

FDA and CDC Investigate Infant Botulism Outbreak - Company Recalls Baby Formula (FDA Update 11/11/2025)

The FDA and CDC, in collaboration with California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP), and state and local partners, are investigating a multistate outbreak of 15 infant botulism illnesses from 12 states (as of the 11/11/25 update).

A few important points to make

• Infant botulism occurs when infants, having yet to establish a stable colonization of their intestinal tract, consume food containing Clostridium botulinum spores.  These spores grow in anaerobic conditions in the intestines, and without a significant competing formula, multiply.  As they grow, they produce botulinum toxin which is absorbed into the bloodstream of the infant.  This toxin is a neurotoxin, which impacts neurotransmission to the autonomic nervous system.
• Infant formula, historically, has not been a known source for infant botulism.  However,  spores can be found in pasteurized milk as well as dried dairy products; this occurring generally through poor sanitary practices.  
• FDA stated that there are 84 cases reported since August 2025.  Only 15 of those cases have reported using this specific formula.  FDA states "According to information shared by IBTPP, since August 1, 2025 through November 10, 2025, 84 infants nationwide have received treatment for infant botulism. Notably, more than 40% (15) infants who had powdered infant formula exposure consumed ByHeart Whole Nutrition infant formula.  This information shows that ByHeart brand formula is disproportionately represented among sick infants in this outbreak, especially given that ByHeart represents an estimated 1% of all infant formula sales in the United States. Investigations remain ongoing but have not identified any other infant formula brands or shared exposures that pose a risk to infants."
• "As part of this investigation, officials in several states have collected leftover infant formula for testing. On November 8, 2025, preliminary laboratory results reported by the California Department of Public Health suggest the presence of the bacteria that produce botulinum toxin in a can of ByHeart infant formula (lot 206VABP/251131P2) that was fed to an infant with infant botulism"
• The company initially only recalled two lots of formula.  However, at FDA's request, the company expanded this recall to include all product.

Case Counts

Total Illnesses: 15
Hospitalizations: 15
Deaths: 0
Last Illness Onset: November 10, 2025
States with Cases: AZ, CA, IL, KY, MN, NC, NJ, OR, PA, RI, TX, WA
Product Distribution: Online and nationwide

Symptoms

• Most infants with infant botulism will initially develop constipation, poor feeding, loss of head control, and difficulty swallowing.
• If untreated, infants with infant botulism experience a progressive, flaccid paralysis that can lead to breathing difficulties and require weeks of hospitalization.
• Treatment with BabyBIG® is recommended for all suspected cases of infant botulism.

Recall - ByHeart, Inc. initially recalled two lots of ByHeart Whole Nutrition Infant formula (Lot: 206VABP/251261P2 and Lot: 206VABP/251131P2) that were reported to have been consumed by the infants.  FDA requested and the company agreed to recall all product sold nationwide.

From FDA According to information shared by IBTPP, since August 1, 2025 through November 10, 2025, 84 infants nationwide have received treatment for infant botulism. Notably, more than 40% (15) infants who had powdered infant formula exposure consumed ByHeart Whole Nutrition infant formula.  This information shows that ByHeart brand formula is disproportionately represented among sick infants in this outbreak, especially given that ByHeart represents an estimated 1% of all infant formula sales in the United States. Investigations remain ongoing but have not identified any other infant formula brands or shared exposures that pose a risk to infants.